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testosterone

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Overview

What is FORTESTA?

FORTESTA is a clear, colorless, odorless, gel containing testosterone. FORTESTA is available in a metered-dose pump. Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. One pump actuation dispenses 0.5 g of gel.

The active pharmacologic ingredient in FORTESTA is testosterone. Testosterone USP is a white to almost white powder described chemically as 17-beta hydroxyandrost-4-en-3-one.

Pharmacologically inactive ingredients in FORTESTA are: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.



What does FORTESTA look like?



What are the available doses of FORTESTA?

FORTESTA (testosterone) Gel for topical use only, is supplied in a metered-dose pump. One pump actuation delivers 10 mg of testosterone.

What should I talk to my health care provider before I take FORTESTA?

How should I use FORTESTA?

FORTESTA is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitations of use:

Prior to initiating, FORTESTA confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.


What interacts with FORTESTA?

Sorry No Records found


What are the warnings of FORTESTA?

Sorry No Records found


What are the precautions of FORTESTA?

Sorry No Records found


What are the side effects of FORTESTA?

Sorry No records found


What should I look out for while using FORTESTA?

Men with carcinoma of the breast or known or suspected prostate cancer. (, )

Pregnant or breastfeeding women. Testosterone may cause fetal harm. (, , )


What might happen if I take too much FORTESTA?

There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdose in the FORTESTA clinical trial.

Treatment of overdosage would consist of discontinuation of FORTESTA, washing the application site with soap and water, and appropriate symptomatic and supportive care.


How should I store and handle FORTESTA?

Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Pre-filled dual chamber syringe:Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use. Vial:Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One pump actuation dispenses 0.5 g of gel.FORTESTA is available in packages of 1, 2 and 3 canisters (NDC 63481-183-16, NDC 63481-183-17 and NDC 63481-183-18, respectively).Store at controlled room temperature 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP]. Do Not Freeze.Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One pump actuation dispenses 0.5 g of gel.FORTESTA is available in packages of 1, 2 and 3 canisters (NDC 63481-183-16, NDC 63481-183-17 and NDC 63481-183-18, respectively).Store at controlled room temperature 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP]. Do Not Freeze.Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One pump actuation dispenses 0.5 g of gel.FORTESTA is available in packages of 1, 2 and 3 canisters (NDC 63481-183-16, NDC 63481-183-17 and NDC 63481-183-18, respectively).Store at controlled room temperature 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP]. Do Not Freeze.Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. The metered dose pump is capable of dispensing 120 metered pump actuations. One pump actuation dispenses 0.5 g of gel.FORTESTA is available in packages of 1, 2 and 3 canisters (NDC 63481-183-16, NDC 63481-183-17 and NDC 63481-183-18, respectively).Store at controlled room temperature 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP]. Do Not Freeze.Used FORTESTA canisters should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.